COSMOS: Guselkumab improves joint, skin symptoms in anti-TNF-refractory PsA
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Guselkumab 100 mg administered every 8 weeks results in “significantly higher” ACR20 response rates vs. placebo in patients with psoriatic arthritis who had an inadequate response to TNF inhibitors, according to data presented at the EULAR 2021 Virtual Congress.
“The COSMOS study provides important information on treatment options for psoriatic arthritis patients for whom we lack data,” Laure Gossec, MD, PhD, of Sorbonne University, in Paris, told Healio Rheumatology. “This includes patients with PsA who have active disease and who have previously received a biologic — in this case, one or more tumor necrosis factor inhibitors. These patients often experience more difficult-to-treat manifestations of the disease.”
To analyze the efficacy and safety of guselkumab (Tremfya, Janssen) in patients with PsA who demonstrated an inadequate response, or intolerance to TNF inhibitors, Gossec and colleagues conducted the randomized, double-blind, placebo-controlled, phase 3b COSMOS study. Investigators randomly assigned 285 participants with at least three swollen and tender joints each, who had failed one or two prior TNF-inhibitor treatments, 2:1 to receive either 100 mg of guselkumab or a placebo. Participants received treatments at weeks 0 and 4, and then every 8 weeks through week 44.
At week 16, participants who met the early escape criteria — defined as less than 5% improvement in both tender and swollen joint counts — were allowed to switch from placebo to guselkumab. At week 24, all those in the placebo group were switched to guselkumab. The primary endpoint was ACR20 response at week 24. All those with missing ACR20 data, or who met the treatment failure criteria, including meeting the early escape threshold at week 16, were counted as non-responders.
The researchers also performed subgroup analyses to examine the consistency of the primary treatment effect, based on baseline demographics, disease characteristics and medication use. Prespecified sensitivity assessments included “per-protocol” (PP), which excluded participants with major protocol deviations, and “EE-correction,” which included those incorrectly routed to early escape, analyses. The researchers summarized adverse events based on treatment received.
According to the researchers, 44.4% of patients who received guselkumab achieved the ACR 20 response, compared with 19.8% of the placebo group, at week 24 (P < .001). In addition, guselkumab was superior to placebo for all major secondary endpoints. At one year, responses increased, with 57.7% of patients who received guselkumab achieving the ACR 20 response, and 53.4% achieving PASI 100.
“At week 24, COSMOS data showed that a significantly higher proportion of patients treated with guselkumab showed joint symptom improvement and complete skin clearance vs. placebo,” Gossec said. “Guselkumab was also superior to placebo in the percentage of patients achieving ACR50 as well as improvement in physical function and health-related quality of life.”
In the subgroup analyses, efficacy was consistent across subgroups defined by baseline characteristics, including in participants who discontinued prior TNF inhibitors due to inadequate efficacy — 84% in the guselkumab group compared with 81% for placebo — and safety — 16% for guselkumab compared with 19% for placebo.
In all, 12 participants in the guselkumab group and eight who received a placebo were incorrectly routed to early escape. Results of the PP — 48.8% compared with 23.8% — and EE-correction — 48.1% compared with 19.8% — sensitivity analyses were consistent with the primary analysis, the researchers wrote. Adverse events were similar for participants in both the guselkumab and placebo groups.
“These results provide promising new data for the efficacy and safety of guselkumab as a therapeutic option for patients with PsA who have not responded to one or more therapies,” Gossec said.
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Coates LC. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who demonstrated inadequate response to tumor necrosis factor inhibition: Week 24 results of a phase 3b, randomized, controlled study. Presented at: EULAR 2021 Virtual Congress; June 2-5, 2021 (virtual meeting).
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